Guides & Documents
European QP Association
EQPA Code of Practice for QPs
– Duties and Responsibilities for Qualified Persons in the EU –
Version 11.0; December 2024
EQPA Code of Practice for QPs
– Duties and Responsibilities for Qualified Persons in the EU –
Annex on National QP Implementation
Version 2.0; December 2024
Please visit the European QP Association website members' area to download the guides.
GMP Auditor Association
ECA Good Practice Guide –
GMP Auditors Reference Handbook
Version 2.0; June 2024
ECA Good Practice Guide –
GMP Auditors Reference Handbook
– Attachment 1: Audit Agenda Template –
Version 3.0; May 2025
ECA Good Practice Guide –
GMP Auditors Reference Handbook
– Attachment 2: Audit Report Template –
Version 3.0; May 2025
ECA Good Practice Guide –
GMP Auditors Reference Handbook
– Attachment 3: Audit Areas and Criteria –
Version 3.0; May 2025
Please visit the GMP Auditor Association website members' area to download the guides.
GDP Association
Good Distribution Practice
Guidance on interpretation and implementation
Version 4.0; March 2018
GOOD DISTRIBUTION PRACTICE FOR ACTIVE
SUBSTANCES
Guidance on interpretation and implementation
Version 4.0; March 2018
Code of Practice
The Responsible Person for GDP
Version 2.0; November 2018
Please visit the GDP Association website members' area to download the guides.
Analytical Quality Control Group
Laboratory Data Management Guidance
– Sampling and Sample Management –
Version 1.0; April 2025
Guide for an Integrated Lifecycle
Approach to Analytical Instrument
Qualification and System Validation
Version 1.0; November 2023
GMP, GCP and GDP
Data Governance and
Data Integrity
Version 3.0; December 2022
STANDARD OPERATING PROCEDURE
Laboratory Data Management;
Out of Specification (OOS) Results
Version 2.1; August 2013
LABORATORY DATA MANAGEMENT GUIDANCE
Out of Expectation (OOE)
and Out of Trend (OOT) Results
Version 1.2; July 2013
Please visit the Analytical Quality Control Group website members' area to download the guides.
ECA Pharmaceutical Microbiology Group
Bioburden – Regulatory
Expectations and Experiences
Questions & Answers
Version 2.0; October 2025
Guidelines for the Evaluation and Investigation of
Microbiological Deviations
Version 1.0; June 2021
Please visit the Pharmaceutical Microbiology Group website members' area to download the guides.
ECA Validation Group
Good Practice Guide
Qualification and Validation
A guide to effective qualification based on custumer-supplier partnership
Vesrion 3.0; November 2024
Validation Good Practice Guide
Vesrion 2.0; 2015
Please visit the Validation Group website members' area to download the guides.
ECA Visual Inspection Group
Visual Inspection of Medicinal
Products for Parenteral Use
Version 5.0; October 2025
Container Closure Integrity Testing of
Medicinal Products for Parenteral Use
– Position Paper –
Version 3.0; November 2025
Please visit the Visual Inspection Group website members' area to download the guides.
Data Integrity & IT Compliance Group
GMP, GCP and GDP
Data Governance and
Data Integrity
Version 3.0; December 2022
STANDARD OPERATING PROCEDURE
Selection Process for Cloud Service Providers
Audit Checklist
PaaS Cloud Service Providers
Audit Checklist
SaaS Cloud Service Providers
Please visit the Data Integrity & IT Compliance Group website members' area to download the guides.
ECA Equipment Design Guide
GMP Equipment Design Guide
Version 1.2; November 2024
Annex 1 Q&As
Questions & Answers on Annex 1
Version 1.1; April 2024
ECA CCS Task Force
How to Develop and Document a Contamination
Control Strategy
Version 2.0; December 2022
Please pelase see the ECA Foundation news section to download the guides.
ECA Cannabis Group
Cannabis Road Map
Version 8.0; 2024